510(k) Report

510(k) · Cleared

Cleared

The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)

K050350510(k) TraditionalCleared Apr 29, 200577-day reviewClass I21 CFR 886.1605

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Notal Vision, Inc. · HPT Perimeter, Automatic, Ac-Powered

Cleared on Apr 29, 2005 as substantially equivalent to K954167 (Carl Zeiss, Inc., 1995) and 3 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1984. 5 later devices descend from it.

Decided
Apr 29, 2005
Review
77 days
Class
Class I
Product code
HPT
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K841099 (1984). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor2009: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant clearedK841099 · Octopus 500/500E · Cilco, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K841099 · Octopus 500/500E · Cilco, Inc. · 19840+5
  1. Root · 1 generation backK841099 Octopus 500/500ECilco, Inc. · 1984
  2. This deviceK050350 The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview…Notal Vision, Inc. · 2005
  3. Descendant · cites it directly · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
  4. Descendant · 2 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
  5. Descendant · 3 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
  6. Descendant · 4 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018
  7. Descendant · 5 generations on · 0 of its ownK203594 EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022

Most influential descendants

Showing 5 of 5 · See all
  • K091579Foresee HomeNotal Vision, Ltd. · 2009 · cites it directly4descendants
  • K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 2 generations on3descendants
  • K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 3 generations on2descendants
  • K180895AlleyeOculocare Medical AG · 2018 · 4 generations on1descendant
  • K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC · 2022 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K841099Octopus 500/500ECilco, Inc.1984—
0 (this device)K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc.2005—
+1K091579Foresee HomeNotal Vision, Ltd.2009—
+2K121738Myvisiontrack (TM)Vital Art and Science Incorporated2013—
+3K143211myVision Track Model 005Vital Art and Science Incorporated2015—
+4K180895AlleyeOculocare Medical AG2018—
+5K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201510
201810
202210
FIG. 1 — Lineage of K050350, 1984–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HPT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K954167Humphrey Field Analyzer (Hfa II)
Summary page 2
…nation of predicate medical devices: * Humphrey Field Analyzer: Perimeter, Automatic, AC-Powered, a class I Exempt medical device (21 CFR 886.1605); (K954167) Product Code HPT * Octopus 500/500e (21CFR 886.1605); (K841099) Product Code HPT. * The Heidelberg Retina Angiog…
Carl Zeiss, Inc.1995—
*K841099Octopus 500/500E
Summary page 2
…: Perimeter, Automatic, AC-Powered, a class I Exempt medical device (21 CFR 886.1605); (K954167) Product Code HPT * Octopus 500/500e (21CFR 886.1605); (K841099) Product Code HPT. * The Heidelberg Retina Angiograph FA/ICGA (HRA/C), (Heidelberg Engineering, Germany) cleare…
Cilco, Inc.1984—
*K971671Heidelberg Retina Angiograph FA/Icga (Hra/C)
Summary page 2
…/500e (21CFR 886.1605); (K841099) Product Code HPT. * The Heidelberg Retina Angiograph FA/ICGA (HRA/C), (Heidelberg Engineering, Germany) cleared under K971671; Product Code HLI * The Macular Computerized Psychophysical Test (MCPT), (Notal Vision, Inc.) cleared under K01…
Heidelberg Engineering1997—
*K014044Mascular Computerized Psychophysical Test (MCPT)
Summary page 2
…g, Germany) cleared under K971671; Product Code HLI * The Macular Computerized Psychophysical Test (MCPT), (Notal Vision, Inc.) cleared under K014044: Product Code HOC * Amsler Grid, a Class I Exempt Preamendments Medical Device (21 CFR 886.1330): Product Code…
Notal Vision, Inc.2002—
*—Amsler Grid
Named without a submission number
—

Also cleared against K954167: 3 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091579Foresee HomeNotal Vision, Ltd.20094

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K091579 (Notal Vision, Ltd., 2009) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K954167.

How does its category compare?

All HPT devices

HPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPT

2in 2010

2007: 12009: 12010: 2
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HPT

Too few HPT 510(k)s in any year since 2007 to give a median.

Recalls per year · HPT

No recall names HPT since 2007.

Adverse event reports per year · HPT

1in 2023

2018: 12022: 12023: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code HPT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20102—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The PreView Preferential Hyperacuity Perimeter (PreView PHPTM) is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

Indications for use as stated in the FDA summary.

Also cleared against K954167

3 other devices cite the same predicate.

  • K150320CompassCentervue S.P.A. · 2015
  • K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc. · 2010
  • K063310Truefield AnalyzerSeeing Machines Limited · 2007

More from Notal Vision, Inc.

3 FDA decisions under this applicant name. See the company

  • DEN230043Notal Vision Home Optical Coherence Tomography (OCT) SystemNotal Vision, Inc. · 2024
  • K014044Mascular Computerized Psychophysical Test (MCPT)Notal Vision, Inc. · 2002

Recent decisions in HPT

The HPT category page

  • K092187Maia, Model 1Centervue S.P.A. · 2010
  • K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc. · 2010
  • K091579Foresee HomeNotal Vision, Ltd. · 2009
  • K063310Truefield AnalyzerSeeing Machines Limited · 2007
  • K023623Novavision, Model 2.0Novavision, Inc. · 2003

https://510kreport.com/device/K050350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050350: The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050350

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026